HIV InfectionsPhase 1/2NCT00917904
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
A Phase 1/2 study testing dapivirine in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by International Partnership for Microbicides, Inc. at 3 sites in South Africa.
Trial summary
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome, Healthy
- What is being tested?
- dapivirine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Jul 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method
- Healthy and self-reported sexually active
- HIV-negative as determined by a HIV rapid test at time of enrollment
- On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment
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- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses
- Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator
- Asymptomatic for genital infections at the time of enrollment
- Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study
- Willing to answer acceptability and adherence questionnaires throughout the study
- Willing to refrain from participation in any other research study for the duration of this study
- Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures
Who cannot join
- Currently pregnant or last pregnancy outcome within 3 months prior to enrolment
- Currently breast-feeding
- Participated in any other research study within 60 days prior to screening
- Previously participated in any HIV vaccine study
- Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment
- Presence of abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
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- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction
- Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Madibeng Centre for Research
Brits, North West
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, Western Cape, 7975
Be Part Clinic, Mbekweni
Paarl, Eastern Cape
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.
Read the detailed description
To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Healthy
- Being tested
- dapivirine, placebo
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, Healthy, HIV seronegativity
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirineDrug
dosage form: vaginal gel
dosage: 1.25mg dapivirine/day
frequency: once daily
duration: 6 weeks
placeboDrug
dosage form: vaginal gel
frequency: once daily
duration: 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| vehicle placebo gel | Placebo comparator | Not described Receives: Drug: placebo |
| dapivirine gel | Experimental | Not described Receives: Drug: dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.
Measured: Week 0, 1, 2, 4, 6 & 10
Safety laboratory tests
Measured: enrollment & last day of gel use
Adverse event/serious adverse event reports
Measured: throughout study
Secondary outcomes (2)
Questionnaires concerning acceptability and adherence to daily use of vaginal gel.
Measured: Week 0, 2, 6 & 10
Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews.
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Annalene Nel, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917904
- Sponsor's protocol ID
- IPM 014B
- Status last verified
- Dec 2011
- First submitted
- 8 Jun 2009
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.
- ClinicalTrials.gov ID
- NCT00917904
- Acronym / sponsor ID
- IPM 014B
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Healthy
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, Healthy, HIV seronegativity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.
Detailed description
To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vehicle placebo gel | Placebo comparator | Drug: placebo |
| dapivirine gel | Experimental | Drug: dapivirine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method
- Healthy and self-reported sexually active
- HIV-negative as determined by a HIV rapid test at time of enrollment
Key exclusion criteria (13 listed)
- Currently pregnant or last pregnancy outcome within 3 months prior to enrolment
- Currently breast-feeding
- Participated in any other research study within 60 days prior to screening
- Previously participated in any HIV vaccine study
- Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dapivirinedosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks | Drug | dapivirine gel |
| placebodosage form: vaginal gel frequency: once daily duration: 6 weeks | Drug | vehicle placebo gel |
Primary outcome
Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.
Time frame: Week 0, 1, 2, 4, 6 & 10
Safety laboratory tests
Time frame: enrollment & last day of gel use
Adverse event/serious adverse event reports
Time frame: throughout study
2 secondary outcomes
Questionnaires concerning acceptability and adherence to daily use of vaginal gel.
Time frame: Week 0, 2, 6 & 10
Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews.
Time frame: throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
- IPM websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Annalene Nel study director
Beijing Immupeutics Medicine Technology Limited
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dapivirine in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by International Partnership for Microbicides, Inc. at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing. (time frame: Week 0, 1, 2, 4, 6 & 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.